NCT02621359

A Two Week Nitazoxanidebased Quadruple Regimen

A Two Week Nitazoxanidebased Quadruple Regimen for Helicobacter Pylori Therapy After Failure of Standard Triple Therapy: A Single Center Experience

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer. Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications . However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries. Treatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .

Detailed description

Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research. Unfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth \[11\]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
DRUG	Nitazoxanide	Nitazoxanide 500 mg twice daily
DRUG	Levofloxacin	Levofloxacin 500 mg once daily
DRUG	Doxycyclin	Doxycyclin 100 mg twice daily
DRUG	Omeprazole	Omeprazole 40 mg twice daily

Timeline

• Start date: 2015-01-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2015-12-03
• Last updated: 2018-01-03

Locations

1 site across 1 country: Egypt